Almirall is seizing the occasion of World Psoriasis Day to underscore the profound impact of this skin condition on mental health. The Spanish pharmaceutical company, known for marketing psoriasis drugs like Ilumetri and Wynzora, has utilized this event to draw attention to its findings regarding patient well-being. Their awareness campaign features a unique narrative miniseries … Read more
The journey to improved treatments for psoriasis, a challenging skin condition, has been long and complex. Despite advances, some patient groups have remained underrepresented in clinical trials. Johnson & Johnson recognized this disparity and embarked on a groundbreaking endeavor, the VISIBLE study, which stands as the first major psoriasis trial exclusively focused on individuals of … Read more
UCB’s long-awaited FDA approval for its psoriasis therapy, Bimzelx (bimekizumab), has finally arrived, ending a journey marked by manufacturing setbacks. The significance of this milestone cannot be understated. Bimzelx stands out as a pioneering psoriasis treatment, working by selectively inhibiting interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two pivotal cytokines intricately involved in the inflammatory … Read more
After a previous setback when the FDA withheld approval for mirikizumab in ulcerative colitis due to manufacturing issues, Eli Lilly’s drug is now making significant progress with positive results in a phase 3 study for Crohn’s disease. In the VIVID-1 study, the interleukin-23p19 antagonist successfully met both primary endpoints and all major secondary endpoints, as … Read more
After facing delays related to manufacturing issues, UCB’s psoriasis medication, bimekizumab, is awaiting the next steps in its FDA review process. The FDA recently concluded its inspection of UCB’s Belgian plant, but the timeline for further actions remains uncertain. UCB had initially anticipated a decision on its second application for bimekizumab in the first half … Read more
Amgen’s bold $13.4 billion investment in Otezla appears to remain robust in the face of competition from Bristol Myers Squibb’s Sotyktu, according to insights from analysts at Spherix Global Insights. These experts have scrutinized the market dynamics and discovered that Amgen is maintaining its market share while limiting BMS’ growth primarily to users of injectable … Read more
Amgen, a major biotech company, has taken an innovative approach to connect with psoriasis patients by using humor in their latest Otezla TV advertisement. In a landscape where most ads and materials about plaque psoriasis focus on the seriousness of the condition, Amgen has chosen to add a lighthearted touch while still acknowledging the mental … Read more
Source – Bristol Myers Squibb Bristol Myers Squibb is striving to provide a comprehensive insight into the challenges of living with psoriasis. In a concerted effort to boost sales of Sotyktu, the pharmaceutical company has initiated a new campaign that zeroes in on enhancing patient understanding and experience. Having gained FDA approval for Sotyktu in … Read more
Source – Abbvie On July 26, 2023 AbbVie announced the publication of results from the Phase IVÂ IMMpulse study in the British Journal of Dermatology, comparing the efficacy and safety of Skyrizi (risankizumab) with Otezla (apremilast) in adult patients with moderate plaque psoriasis eligible for systemic therapy. The study achieved all primary and secondary endpoints, … Read more
Source – Johnson & Johnson On July 4, 2023, Janssen, a subsidiary of Johnson & Johnson announced positive initial results from the Phase IIb FRONTIER 1 trial, which evaluated the effectiveness of JNJ-2113, a new oral interleukin-23 receptor antagonist peptide, in adults with moderate-to-severe plaque psoriasis. JNJ-2113 is an oral peptide that functions as an … Read more
Source: Bristol-Myers Squibb Just weeks after receiving approval in the UK, Bristol-Myers Squibb’s novel oral therapy for psoriasis, SotyKtu, has been recommended for routine use by the National Health Service (NHS) in England and Wales. The National Institute for Health and Care Excellence (NICE) has endorsed the use of Soty Ktu, the first-in-class Tyk2 inhibitor, … Read more
Ventyx Biosciences discovered that even a seemingly successful clinical trial may not be enough to support a drug’s advancement, as they reviewed data from a phase 2 trial of the TYK2 inhibitor VTX958 for moderate to severe plaque psoriasis. The study showed that the two higher doses, 225 mg and 300 mg, out of the … Read more
MoonLake Immunotherapeutics has achieved promising results in a phase 2 trial for its IL-17 inhibitor, sonelokimab, aimed at treating inflammatory skin conditions, particularly psoriatic arthritis. The trivalent camelid nanobody showed a statistically significant response in patients with active psoriatic arthritis, with 46% and 47% of those receiving the 60-mg and 120-mg doses, respectively, experiencing a … Read more
Novartis’ Cosentyx has gained an early lead in the field of hidradenitis suppurativa (HS), a painful skin condition, potentially giving it an edge over a strong contender, UCB’s bimekizumab. Novartis recently announced that the FDA has granted approval for Cosentyx (secukinumab) to treat moderate to severe HS in adults. This approval marks a significant milestone, … Read more
The FDA has granted approval to Amgen for its biosimilar rendition of Johnson & Johnson’s renowned autoimmune medication, Stelara. However, Amgen’s new product won’t be hitting the market anytime soon. In May, as part of an agreement between the two pharmaceutical giants, Amgen consented to postpone the launch of its Stelara biosimilar in exchange for … Read more
Eli Lilly, known for its weight loss contender Mounjaro, is making strides in the immunology arena. The FDA has granted approval to Lilly’s mirikizumab, marketed as Omvoh, making it the first IL-23 inhibitor to enter the competitive ulcerative colitis landscape, where it joins established biologics from AbbVie, Johnson & Johnson, and Takeda. This recent approval … Read more
UCB Farchim, a subsidiary of Belgian pharmaceutical company UCB, is facing regulatory scrutiny from the FDA. The FDA recently issued a Form 483 to the UCB Farchim facility in Bulle, Switzerland, following an inspection conducted from June 26 to July 4. This regulatory action centres on concerns related to quality control and record-keeping. The FDA … Read more
UCB is celebrating an impressive streak of FDA approvals, securing the green light for both the plaque psoriasis treatment Bimzelx and the generalized myasthenia gravis (gMG) drug Zilbrysq within hours of each other. This latest approval for Zilbrysq marks UCB’s second triumph in the gMG indication this year, following the FDA’s endorsement of Rystiggo in … Read more
In a series of unfortunate turns, Evelo Biosciences, a biotech company backed by Flagship Ventures and that went public in 2018, has encountered substantial challenges over the past year. Their lead candidate faltered in clinical trials, and now their next-generation asset has performed worse than a placebo in a phase 2 psoriasis trial, prompting the … Read more
Dermavant is advancing in the race to develop nonsteroidal topical treatments for autoimmune skin conditions, building on its FDA approval of Vtama for plaque psoriasis last year. The company has presented data at the European Academy of Dermatology and Venereology Congress, showcasing Vtama’s potential to provide immediate and sustained relief from pruritus, a severe itch … Read more
Immunic Therapeutics’ strategic decision to refocus its efforts earlier this year appears to be yielding positive results, drawing favorable reactions from investors in response to early biomarker data from its multiple sclerosis (MS) candidate. The biotech has been conducting a phase 2 trial of vidofludimus calcium, an inhibitor of dihydroorotate dehydrogenase, in patients with progressive … Read more
AnaptysBio has unveiled promising phase 3 data for its rare skin disease drug candidate, indicating a potential challenge to Boehringer Ingelheim’s position in generalized pustular psoriasis (GPP). Anaptys, headquartered in San Diego, originally intended to bring imsidolimab to the US market independently. However, after imsidolimab’s phase 2 trial for hidradenitis suppurativa proved unsuccessful last year, … Read more
Amgen has successfully concluded its monumental $27.8 billion acquisition of Horizon Therapeutics, triumphing over a legal challenge posed by the US antitrust watchdog. The announcement of this significant milestone came from the California-based pharmaceutical giant on a momentous Friday, following the formal approval from the High Court of Ireland the day prior. Originally unveiled in … Read more
Arcutis Biotherapeutics, riding high on a dermatology approval and another on the horizon, has enlisted L. Todd Edwards as its new Chief Commercial Officer to bolster its commercial endeavors. Edwards will spearhead the company’s strategic commercial launch plans for two key products: Zoryve, an FDA-approved plaque psoriasis cream, and a modified foam variant of the … Read more
In the race to capture a share of the $20 billion annual revenue generated by AbbVie’s blockbuster biologic, Humira biosimilars have made their presence known this year. However, according to an analysis by Spherix Global Insights, these biosimilars have yet to make a substantial impact on the market. The analysis highlights a “continued erosion” of … Read more
Bristol Myers Squibb is placing a significant bet on its robust pipeline to weather challenges such as the Inflation Reduction Act and impending patent losses. Despite facing headwinds, BMS has demonstrated its research and development prowess, securing nine FDA approvals and more than 45 global regulatory nods in the past three years. BMS now aims … Read more
AbbVie’s revolutionary anti-inflammatory medication, Skyrizi, has been consistently outperforming its competitors in recent clinical trials, making waves in the field of inflammatory diseases. In its latest triumph, Skyrizi has gone head-to-head with Johnson & Johnson’s Stelara in a successful study focusing on Crohn’s disease treatment. The results are nothing short of impressive: Skyrizi not only … Read more
Sandoz is expanding its biosimilar portfolio by signing a commercialization agreement with Samsung Bioepis for a biosimilar version of Johnson & Johnson’s immunology drug Stelara. The deal encompasses commercial rights in the US, Canada, Switzerland, the UK, and various European countries. The specific terms of the agreement have not been disclosed. With this strategic move, … Read more
Nimbus Therapeutics, with its experienced leadership, well-established R&D platform, and substantial financing, appears well-positioned for success in the public markets. In its most recent private financing round, the company secured an impressive $210 million, bringing its total financing to over $600 million since its inception approximately 14 years ago. This new funding injection, revealed recently, … Read more
Amid the ongoing legal battle with the Federal Trade Commission (FTC) over its $28 billion acquisition of Horizon Therapeutics, Amgen has responded with strong assertions in court documents. In response to the FTC’s request for a preliminary injunction, Amgen’s legal team has stated that the FTC’s case is detached from reality and lacks grounding in … Read more
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